Gilead's liver disease drug Seladelpar files for approval in China

On November 12, the official website of China's Center for Drug Evaluation (CDE) showed that the marketing application for seladelpar, an innovative drug from Gilead Sciences targeting primary biliary cholangitis (PBC), has been officially accepted.

This marketing application is not the first time seladelpar has entered the Chinese public view. In August 2025, the drug was approved under Beijing's clinical urgent import policy within the Beijing Tianzhu Rare Disease Drug Security Pilot Zone. It was designated for use in combination with ursodeoxycholic acid (UDCA) for adult PBC patients who have responded inadequately to UDCA, or as a monotherapy for those intolerant to UDCA. The current acceptance of the application by the CDE indicates that seladelpar is now positioned to potentially benefit Chinese patients through the formal regulatory approval pathway.

Primary biliary cholangitis (PBC) is a rare chronic autoimmune liver disease that primarily affects the small bile ducts within the liver, leading to cholestasis, liver fibrosis, and potentially progressing to cirrhosis or even liver failure.

Seladelpar is a potent and selective peroxisome proliferator-activated receptor delta (PPARδ) agonist. Its mechanism of action involves activating the PPARδ receptor to exert multi-faceted therapeutic effects in PBC: on one hand, it inhibits CYP7A1, a key enzyme in bile acid synthesis, thereby reducing bile acid production while promoting bile excretion to alleviate cholestasis; on the other hand, it suppresses the NF-κB pathway, reducing the release of pro-inflammatory factors and mitigating liver inflammation. Additionally, it modulates lipid metabolism by lowering low-density lipoprotein cholesterol and triglyceride levels, thereby slowing the progression of liver fibrosis and addressing multiple pathological processes in PBC.

In August 2024, seladelpar received accelerated approval from the U.S. FDA for use in combination with ursodeoxycholic acid (UDCA) in adults with PBC who have had an inadequate response to UDCA, or as a monotherapy for those intolerant to UDCA.

According to a Coherent Market Insights report, the global PBC treatment market was valued at $526 million in 2017 and is projected to maintain a compound annual growth rate (CAGR) of 36.3% over the next decade, reaching $8.593 billion by 2026. This growth trajectory provides substantial market potential for innovative drugs like seladelpar. In China, the prevalence of PBC is approximately 20.5 per 100,000 people, with female patients accounting for over 90% of cases and the peak incidence occurring between 40 and 65 years of age.

Currently, ursodeoxycholic acid (UDCA) serves as the first-line treatment for PBC. However, approximately 40% of patients exhibit an inadequate response or intolerance to UDCA. While the second-line drug obeticholic acid (OCA) demonstrates certain efficacy, its clinical application is limited by adverse effects such as severe pruritus. The introduction of seladelpar offers a new therapeutic option for these patients, addressing the unmet need when conventional treatments prove insufficient.

Although several drugs have been approved for PBC treatment, the overall market remains unsaturated. As the first targeted therapy in PBC to simultaneously achieve improvements in biochemical markers, alkaline phosphatase (ALP) normalization, and pruritus control, seladelpar is well-positioned to distinguish itself in the competitive landscape and become the standard second-line treatment for patients with an inadequate response to or intolerance of UDCA.